The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes.
Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel.
연구 개요
상세 설명
One of main reason of nocturia is known as nocturnal polyuria. For the treatment of nocturia caused by overactive bladder, the combined therapy of anticholinergics plus behavioural modification has been established as the first line therapy. However, nocturia mainly comes from polyuria has been treated with desmopressin pharmacotherapy and the effect of behaviour modification education has not yet evaluated. Therefore, in this study, short term synergistic effect of combinational treatment of desmopressin and SyBeMeP (Systemized Behavioral Modification education Program) comparing desmopressin monotherpy will be evaluated in patients with nocturia.
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP. Patients will be randomized and assigned to each group at the ratio of 1:1. At screening visit, flowmetry and residual urine measurement, Complete Blood Count (CBC), atypical diabetes mellitus (ADM), electrolytes, urinalysis micro, urine concentration, and demographic examination will be done. Voiding diary will be distributed. At 2nd visit, patients will be randomized and each treatment will be initiated. IPSS, ICIQ-nocturia, and PPTB will be completed. Voiding diary will be distributed. At 3rd visit (2 weeks after from 2nd visit): IPSS, ICIQ-nocturia, and PPTB will be completed. Assess the treatment outcome including voiding diary analysis.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Seoul, 대한민국, 110-744
- Seoul National University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- A patient with nocturia, who visited department of urology as outpatient
- Have not been treated with desmopressin for at least 6 months before
Exclusion Criteria:
- Sleep disorder,
- history of medication for voiding,
- diabetes insipidus,
- diabetes mellitus,
- cardiovascular disease,
- voiding difficulties (including residual urine of more than 100ml),
- small bladder capacity,
- overactive bladder,
- illiteracy,
- psychiatric disorder and having no intention to be enrolled by written agreement
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Desmopressin monotherapy
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day)
+ simple instruction
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Combination group
Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP * Patients will be randomized and assigned to each group at the ratio of 1:1. |
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Decrease in urinary frequency (No. of nocturia)
기간: baseline, 2 week, 1 month, and 3 months
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baseline, 2 week, 1 month, and 3 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Voiding diary indices
기간: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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IPSS
기간: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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ICIQ-nocturia
기간: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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patient's perception of bladder condition (PPTB)
기간: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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patient's satisfaction on the education
기간: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Sung Yong Cho, M.D.,Ph.D., Seoul National University Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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